cmAngio®

Simple. Safe. Fast. Effective.

The first and only FDA-cleared, AI-based SaaS solution that detects, quantifies and contextualizes breast arterial calcifications (BAC) on routine screening mammograms — with an AUC of 0.98-0.99 across FFDM and DBT1. Turns a mammogram into a 2-for-1 exam: breast cancer screening and BAC assessment in one visit.

Results in minutes. Read in seconds.

No additional radiation. No new procedures.

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cmAngio V2.0 Scorecard — Present Bilateral, 59th PercentilecmAngio V2.0 Scorecard — Present Bilateral, 64th PercentilecmAngio V2.0 Scorecard — Present Bilateral, 82nd Percentile

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Detect. Quantify. Contextualize.

Detect

“Present” or “Present Bilateral”

cmAngio Detect — BAC detection showing Present or Present Bilateral result on mammogram
  • Detects BAC when present and identifies whether findings are unilateral or bilateral across mammogram views

Quantify

Normalized BAC Length

cmAngio Quantify — BAC Length and Normalized BAC Length measurements
  • Quantifies BAC extent with BAC lengths at the view and study level and normalized BAC Length to allow for comparison across varying breast sizes

Contextualize

Age-Based Percentile & Prevalence

cmAngio Contextualize — Age-Based Percentile & Prevalence graph from CureMetrix Reference Library
  • Contextualizes BAC with Age-Based Percentile and Prevalence using the CureMetrix Reference Library derived from 170K+ studies

Understanding Breast Arterial Calcifications

Breast Arterial Calcifications are medial calcifications, different from intimal calcifications, of varying attenuation and length along the walls of the arteries and are currently considered a benign incidental finding in screening mammograms.

Among women who have had screening mammograms, the prevalence of BAC varies from around 12 to 25%2,3. However, less than 5% of BAC in mammograms are reported.

Breast Arterial Calcification

cmAngio Key Features

Built for clinical workflows with flexibility, security, and ease of integration.

Adjustable Operating Point

Adjustable operating point to meet clinical goals and workflow preferences.

FFDM & DBT Processing

Processes both Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) For Presentation exams from GE and Hologic.

Easy Integration

FHIR-enabled JSON output supports streamlined EHR integration and downstream interoperability.

Automated Processing

BAC segments are localized, marked and displayed on scorecard for review.

Batch Read Ready

Results are returned in minutes and can be read in seconds. Cleared on screening mammograms for women aged 40-90.

All Densities

Demonstrated performance across all breast densities.

Easy to Implement

PACS agnostic & cloud-based
HIPAA and DICOM compliant
No hardware to install or software to integrate
FHIR JSON
ISO 13485 compliant
MDSAP compliant
PACS to cmAngio Cloud Architecture — Staged and anonymized DICOM data flows through cmEdge Client to cmAngio Cloud with encrypted transport

4-WEEK IMPLEMENTATION

1

Week 1

Foundation & Alignment

Kickoff meeting with key stakeholders
Site and workflow discovery
Roles, responsibilities, and success criteria defined
2

Week 2

Technical Deployment

cmAngio software installation and configuration
Reporting templates and BAC documentation protocols established
Patient communication and marketing materials prepared
3

Week 3

Operational Readiness

Staff education and patient-facing messaging activated
End-to-end workflow validated across all relevant teams
Referring physician outreach initiated
4

Week 4

Go-Live

End-to-end system and workflow testing completed
Final sign-off from clinical and technical leads
cmAngio goes live

CureMetrix Platform Components

All tailored for your practice

Implementation Resources
Educational Materials
Hands on Support
Marketing Materials
Customizable Output
Technical Documentation
Useful Guides and FAQ
Insight and Analytics Dashboard
cmAngio Platform Components — Email templates, physician guides, patient FAQ, analytics dashboard, marketing materials, and technical manuals

Regulatory Timeline

FDA clearance and ANVISA notifications support cmAngio's growing global presence.

FDA Cleared

V1.0 — K232367

October 2023

Initial FDA 510(k) clearance for breast arterial calcification detection and localization on FFDM and DBT for Hologic Image Acquisition Systems.

ANVISA NOTIFIED

V1.0 — NOTIFICATION No. 81464750139

March 2024

Brazilian Health Regulatory Agency clearance for commercial distribution in Brazil.

FDA Cleared

V1.6 — K250754

April 2025

Expanded clearance to support GE Image Acquisition Systems.

ANVISA NOTIFIED

V1.6 — NOTIFICATION No. 81464750139

April 2026

Updated ANVISA notifications for expanded modality support and commercial availability.

FDA Cleared

V2.0 — K260980

July 2026

FDA-cleared next-generation platform introducing BAC quantification, age-based contextualization, enhanced scorecards, CureMetrix Reference Library, and FHIR-enabled interoperability.

BAC Detection, Quantification, and Contextualization Starts Here

See how cmAngio can unlock BAC insights from existing mammography workflows, empowering care teams with actionable detection data.

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References

  1. [1]FDA 510(k) K260980 — cmAngio AI-based software for breast arterial calcification detection and localization. Performance data on file.
  2. [2]Loberant et al. "Prevalence and Degree of Breast Arterial Calcifications on Mammography: A Cross-sectional Analysis." Journal of Clinical Imaging Science, vol. 3, 27 Sep. 2013. doi:10.4103/2156-7514.11901
  3. [3]Iribarren et al. "Breast Arterial Calcification: a Novel Cardiovascular Risk Enhancer Among Postmenopausal Women." JACC: Advances, 2022.